Medsafe's Compliance Review

Tuesday, March 25th 2008

25th March.
Those of you in the NHP business will no doubt have heard about the compliance review Medsafe launched shortly after their ANZTPA plan was scuttled. Under this review, teams of auditors have been assessing many natural health products for breaches of the Medicines Act and the Dietary Supplements Regulations. In many cases though, where there are breaches, these are matters that have been openly allowed by Medsafe for many years. Medsafe themselves told the Health Select Committee that current laws were not being enforced because doing so would force a substantial proportion of existing complementary healthcare products off the market. They also said that current Medicines Act rules were not appropriate for use for natural products. We can't help but see their decision to now ruthlessly enforce these very same matters as an act of retaliation against the industry for standing up to them on ANZTPA.

The review seems to be targeting two key areas. Firstly the making of any therapeutic claim (no matter how well established) and secondly the inclusion of any listed "medicine" in a dietary supplement notwithstanding that listed medicine may be something as innocuous as Vitamin B12 or folate over a very small level. The effect of this is that many products are right now being forced from sale despite any real evidence of public harm being caused by them, and many businesses are threatened with closure.

Copied from NZ Health Trust Newsletter No 45
www.nzhealthtrust.co.nz